Brentuximab Vedotin Combo Earns European Approval in Hodgkin Lymphoma

The European Commission has granted approval to brentuximab vedotin (Adcetris) plus doxorubicin (Adriamycin), vinblastine, and dacarbazine (AVD) for adult patients with previously untreated CD30-positive stage III Hodgkin lymphoma, according to a news release from Takeda.¹

Supporting data for the European approval came from the phase 3 ECHELON-1 trial (NCT01712490). According to previously published findings, brentuximab vedotin plus AVD produced a 6-year overall survival (OS) rate of 93.9% (95% CI, 91.6%-95.5%) vs 89.4% (95% CI, 86.6%-91.7%) in patients treated with bleomycin plus AVD, resulting in a 41% reduction in the risk of death with the experimental regimen (HR, 0.59; 95% CI, 0.40-0.88; P = .009).² The 6-year progression-free survival rate in each respective arm was 82.3% (95% CI, 79.1%-85.0%) vs 74.5% (95% CI, 70.8%-77.7%).³

Treatment with brentuximab vedotin in the ECHELON-1 trial raised no new safety signals.

“ECHELON-1 is the first trial to show a statistically significant improvement in [OS] outcomes for adult patients with stage III and IV Hodgkin lymphoma in two decades, demonstrating the benefit [brentuximab vedotin] continues to bring to a broad group of patients,” lead investigator John Radford, MD, FMedSci, a professor of medical oncology at the University of Manchester and the Christine NHS Foundation, said in the news release.¹ “This approval is an exciting advancement in care, allowing even more [patients with] lymphoma to access the proven efficacy, consistent safety, and tolerability that [brentuximab vedotin] is known to deliver.”

The FDA approved brentuximab vedotin plus chemotherapy for patients with previously untreated stage III or IV classical Hodgkin lymphoma in March 2018.⁴ The agency’s approval was supported by findings from the ECHELON-1 trial.

References

1. European Commission approves ADCETRIS® (brentuximab vedotin) for the treatment of adult patients with previously untreated CD30+ stage III Hodgkin lymphoma in combination with AVD. News release. Takeda. October 18, 2023. Accessed October 19, 2023. https://shorturl.at/hAPU9
2. Ansell SM, Radford J, Connors JM, et al. Overall survival with brentuximab vedotin in stage III oor IV Hodgkin’s lymphoma. N Engl J Med. 2022;387:310-320. doi:10.1056/NEJMoa2206125
3. Six-year overall survival results added to U.S. prescribing information for ADCETRIS® (brentuximab vedotin) as first-line treatment for advanced Hodgkin lymphoma. News release. June 14, 2023. Accessed October 19, 2023. bit.ly/3NdL9j6
4. Brentuximab vedotin. FDA. March 20, 2018. Accessed October 19, 2023. https://shorturl.at/gP347